FDA.reportPublic FDA data

acetaminophen pm

Product NDC
41163-515
Requested package NDC
41163-515-01
11-digit product format
411630515
Labeler code
41163
Product ID
41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
acetaminophen pm
Brand name suffix
extra strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f86a11af-6d3c-4638-870d-a663ddf49371Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-515-01acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-01acetaminophen pmextra strength24 in 1 BOTTLE, PLASTICTABLET, COATED2410
41163-515-02acetaminophen pmextra strength50 in 1 BOTTLE, PLASTICTABLET, COATED5010
41163-515-02acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-03acetaminophen pmextra strength100 in 1 BOTTLE, PLASTICTABLET, COATED10010
41163-515-03acetaminophen pmextra strength1 in 1 CARTONTABLET, COATED110
41163-515-14acetaminophen pmextra strength200 in 1 BOTTLE, PLASTICTABLET, COATED20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-515-01EA - Each41163-5155c6c8447-ffdb-4a36-ad82-f857e36fb2a512016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-515ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]10Current NDC, Legacy NDC, 7 package rows20241019_f86a11af-6d3c-4638-870d-a663ddf49371.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 40 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmacaf5daea-409e-5dd2-e053-2995a90acb122025-08-18WarningsExact identifier
application number: M013
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
application number: M013
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
application number: M013
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
application number: M013
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions44b8c203-37c5-425e-9110-f7eb614f9c2d2025-08-08WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION INCc46688ec-e976-4f76-9265-645f59970ff52025-08-06WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
application number: M013
AspirinASPIRINMarlex Pharmaceuticals Inc.cc7013ea-cf30-6f59-e053-2a95a90a11482025-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
application number: M013
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf86a11af-6d3c-4638-870d-a663ddf4937110
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf86a11af-6d3c-4638-870d-a663ddf4937110
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf86a11af-6d3c-4638-870d-a663ddf4937110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-515-01411630515011 BOTTLE, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-09-010000-00-00NoNoCurrent